HIV & Drug Abuse Prevention for South African Men
Human Immunodeficiency Virus
Behavioral: Soccer League (SL)
Behavioral: Soccer League/Vocational Training (SL-V)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||HIV & Drug Abuse Prevention for South African Men|
- Substance Abuse [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Alcohol and drug use assessed repeatedly using point-of-contact, rapid diagnostic tests over 24 months; Hazardous alcohol use and dependence symptoms self-reported repeatedly over 24 months using the AUDIT-C (a three-item questionnaire)
- Recent HIV testing [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports of HIV tests over 24 months
- Concurrent sexual partnerships [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Employment [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports of employment over 24 months, validated by external documentation
- Violence towards Women [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports of violence towards women over 24 months, validated by external documentation
- Among HIV+, uptake and adherence to ARV medications and medical regimens [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Density and centrality of social networks [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Community and personal norms regarding HIV stigma, alcohol use, healthy nutrition, and hopefulness for the future [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Consistency of daily routines [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Partner's behaviors, and involvement of female partners and father in the home life [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
- Values, life goals, and goal for the next month [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]Assessed via repeated self-reports over 24 months
|Study Start Date:||July 2015|
|Estimated Study Completion Date:||June 2021|
|Estimated Primary Completion Date:||June 2021 (Final data collection date for primary outcome measure)|
Experimental: Soccer League (SL)
In the SL arm, participants will be invited to participate in a Soccer League, led by coaches who meet the criteria of: 1) soccer skills, 2) being a role model, and 3) social competence. Coaches will undergo intensive training in ethics; role-playing the delivery of health messages; conducting brief interventions for alcohol; how to acquire information on HIV, TB, alcohol use and employment; linkages to local clinics, data collection; and Street Smart, an evidence-based intervention for high-risk youth. Coaches will provide pre- and post-game talks, incorporating the topics of alcohol and drugs; interacting positively with health care providers, partners and family members; HIV, diabetes; daily routines; healthy social networks; making and saving money; loyalty and national success.
Behavioral: Soccer League (SL)
Participants will be invited to attend soccer practice in the late afternoons, roughly 2-3 times per week. Competitive games will be held on Saturdays so that friends and family may attend. Using a mobile phone application, coaches will regularly record information on participants' arrival and departure times, sportsmanship, volunteering in the community, the results of saliva tests for drugs and alcohol. The SL intervention arm will last for one year.
Experimental: Soccer League/Vocational Training (SL-V)
The SL-V arm will include both the SL intervention as well as access to Vocational Training at Khayelitsha College. The program covers several different skills (e.g., math, engineering), including a trade. If participants are able to demonstrate near-perfect attendance, and at least a 50% pass rating in math, engineering and trade theory and practice, their names will be listed in a national artisan database with guaranteed work placement by the recruiting company.
Behavioral: Soccer League/Vocational Training (SL-V)
In addition to the SL intervention, participants will gain access to vocational training. The Vocational Training will take place at Khayelitsha College for a period of 6 months with assessments at the halfway mark. If participants demonstrate near-perfect attendance, and a pass rating of at least 50% in math, engineering, and trade theory and practice, their names will be listed in a national artisan database with guaranteed work placement by recruiting companies. The SL-V intervention arm will last for one year; with six months dedicated to soccer and six months dedicated to vocational training.
No Intervention: Control Condition (CC)
Participants in the CC arm will routinely receive flyers with picture stories regarding HIV prevention strategies and how to access these strategies: HIV testing, circumcision, HIV treatment, including ARV, condoms and sexually transmitted diseases.
South Africa has the highest number of HIV-infected persons of any nation, including 2.4 million men, and from 2002-2011 young men had a 3% incidence HIV rate that has remained stable (UNAIDS et al., 2011; Barnighausen et al., 2009; Statistics, South Africa, 2013). New infections occur later in men than in women, making men in their 20s a target for intervention (Statistics, South Africa, 2013). Decreasing sexual risk and concurrent partnerships is a key outcome in interventions to reduce HIV incidence (Aral & Peterman, 1996; Epstein, 2007). Most men (68%) report unprotected sex, typically with three partners in the last three months,and more than half of young men do not use condoms with casual partners (Bhana & Pattman, 2009; Reddy et al., 2003; SA DoH & Medical Research Council, 2007; Coovadia et al., 2009).
In South Africa, the amount of alcohol consumed per adult is among the highest in the world (Parry, 2005). 'Heavy episodic drinking', which most strongly correlates with risky sexual behaviors and HIV infection, is reported by 60% of men (Scott-Sheldon et al., 2012). Alcohol, tik (methamphetamine) and marijuana are common among young men in South Africa (Morojele et al., 2006; Parry et al., 2004; Kalichman et al., 2008). Among alcohol abusers, men are highly likely to be poly substance users (Parry & Bennetts, 1998). Among HIV seropositive young men, drug use is common (Parry & Bennetts, 1998). Drug and alcohol use is associated with risky sexual behaviors and an increase in the number of sexual partners (Morojele et al., 2006; Simbayi et al., 2006).
In townships, alcohol is involved in or responsible for 60% of automobile accidents, 75% of homicides, 50% of non-natural deaths, 67% of domestic violence, 30% of hospital admissions, and costs South Africa about R9 billion annually (Parry, 2005; MRC, 2003). Violence also characterizes the lives of young men in the Xhosa townships. Intimate partner violence is frequent in alcohol-using partnerships and is correlated with increased HIV incidence (Jewkes, 2002; Jewkes et al., 2010). Substance use and unemployment often lead to violence in a township. Jobs, by contrast, provide income and create a strong and respected community role.
HIV prevention efforts for young people in Sub-Saharan Africa have largely been unsuccessful: novel, structural, community level programs that address the social determinants of HIV are needed (Michielsen et al., 2010; Dean & Fenton, 2010; UNAIDS, 2010; Gupta et al., 2008). Unemployment and a culture of alcohol and violence are major social determinants of HIV among young men. Yet, men are often excluded from economic development programs. Young, South African men need new pathways for prosocial roles and behaviors and our interventions need to be attractive and consistent with men's styles. The social determinants of HIV (unemployment, alcohol, and violence) are critical to creating opportunities for prosocial roles for young men. One of the most common comments by both the men and their families in our previous pilot qualitative study on soccer and vocational training was men's lack of "things to do." Given these needs, the investigators focus on soccer and vocational training in this randomized controlled trial as opportunities for young men to acquire the habits of daily living that are most likely to result in jobs, health, and positive relationships.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02358226
|Contact: Mary Jane Rotheram, PhD||(310) firstname.lastname@example.org|
|Contact: Mark Tomlinson, PhD||+27 (21) email@example.com|
|Cape Town, South Africa|
|Contact: Kelly Baird +27 21 426 5154|
|Stellenbosch, South Africa|
|Contact: Mark Tomlinson, PhD +27-21-8083461|
|Principal Investigator: Mark Tomlinson, PhD|
|Principal Investigator:||Mary Jane Rotheram, PhD||Department of Psychiatry & Biobehavioral Sciences, Semel Institute, UCLA|